Ipratropium Bromide Inhalation

Ipratropium Bromide Inhalation is an FDA-registered drug product whose active ingredient is IPRATROPIUM BROMIDE INHALATION. It is labelled by Armstrong Pharmaceuticals, Inc. taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 17270-0401, application ANDA217953, label effective 20260416. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing IPRATROPIUM BROMIDE INHALATION are most often described in connection with: ipratropium bromide, hfa inhalation, maintenance treatment, bronchospasm associated, chronic obstructive, pulmonary disease, copd including, aerosol indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Ipratropium bromide HFA inhalation aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Ipratropium bromide HFA inhalation aerosol is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

2 DOSAGE AND ADMINISTRATION The usual starting dose of ipratropium bromide HFA inhalation aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Ipratropium bromide HFA inhalation aerosol is a solution aerosol that does not require shaking. However, as with any other metered-dose inhaler, some coordination is required between actuating the canister and inhaling the medication. Patients should “prime” or actuate ipratropium bromide HFA inhalation aerosol before using for the first time by releasing 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 3 days, prime the inhaler again by releasing 2 test sprays into the air away from the face. Patients should avoid spraying ipratropium bromide HFA inhalation aerosol into their eyes. Each inhaler provides sufficient medication for 200 actuations. The inhaler should be discarded after the labeled number of actuations has been used. The amount of medication in each actuation cannot be assured after this point, even though the canister is not completely empty. Patients should be instructed on the proper use of their inhaler [see Patient Counseling Information ( 17 )]. For oral inhalation only • Two inhalations four times a day, not to exceed 12 inhalations in 24 hours

4 CONTRAINDICATIONS Ipratropium bromide HFA inhalation aerosol is contraindicated in the following conditions [see Warnings and Precautions ( 5.2 )]. • Hypersensitivity to ipratropium bromide or other ipratropium bromide HFA inhalation aerosol components • Hypersensitivity to atropine or any of its derivatives • Hypersensitivity to ipratropium bromide or other ipratropium bromide HFA inhalation aerosol components ( 4 ) • Hypersensitivity to atropine or any of its derivatives

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Hypersensitivity Reactions, Including Anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] • Paradoxical Bronchospasm [see Warnings and Precautions ( 5.3 )] • Ocular Effects [see Warnings and Precautions ( 5.4 )] • Urinary Retention [see Warnings and Precautions ( 5.5 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients. Most common adverse reactions (>5% incidence in the 12-week placebo- controlled trials) were bronchitis, COPD exacerbation, dyspnea, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Armstrong Pharmaceuticals, Inc. at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The adverse reaction information concerning ipratropium bromide HFA inhalation aerosol is derived from two 12-week, double-blind, parallel-group studies and one 1-year open-label, parallel group study. These studies compared ipratropium bromide HFA inhalation aerosol, ipratropium bromide CFC inhalation aerosol, and placebo (in one study only) in 1,010 COPD patients. The following table lists the incidence of adverse reactions that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group and greater than placebo in the 12-week study. The frequency of corresponding reactions in the 1-year open label study is included for comparison. TABLE 1 Adverse Reactions (% Patients) in Ipratropium Bromide HFA Inhalation Aerosol Clinical Trials Placebo-controlled 12-week study 244.1405 and Active-controlled 12-week Study 244.1408 Active-controlled 1-year Study 244.2453 Ipratropium Bromide HFA Inhalation Aerosol (N=243) % Ipratropium Bromide CFC Inhalation Aerosol (N=183) % Placebo (N=128) % Ipratropium Bromide HFA Inhalation Aerosol (N=305) % Ipratropium Bromide CFC Inhalation Aerosol (N=151) % BODY AS A WHOLE - GENERAL DISORDERS Back Pain 2 3 2 7 3 Headache 6 9 8 7 5 Influenza-like symptoms 4 2 2 8 5 CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS Dizziness 3 3 2 3 1 GASTROINTESTINAL SYSTEM DISORDERS Dyspepsia 1 3 1 5 3 Mouth dry 4 2 2 2 3 Nausea 4 1 2 4 4 RESPIRATORY SYSTEM DISORDERS Bronchitis 10 11 6 23 19 COPD exacerbation 8 14 13 23 23 Dyspnea 8 8 4 7 4 Sinusitis 1 4 3 11 14 URINARY SYSTEM DISORDER Urinary tract infection 2 3 1 10 8 Cough, rhinitis, and upper respiratory infection occurred in greater than or equal to 3% of patients in either ipratropium treatment group but not greater than placebo in the 12-week study. In the one open-label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between ipratropium bromide HFA inhalation aerosol and ipratropium bromide CFC inhalation aerosol formulations. Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ipratropium bromide HFA inhalation aerosol and 8.7% of the patients taking 42 mcg ipratropium bromide CFC inhalation aerosol reported at least one adverse event that was considered by the investigator to be related to the study drug. The most common drug-related adverse events were dry mouth (1.6% of ipratropium bromide HFA inhalation aerosol and 0.9% of ipratropium bromide CFC inhalation aerosol patients), and taste perversion (bitter taste) (0.9% of ipratropium bromide HFA inhalation aerosol and 0.3% of ipratropium bromide CFC inhalation aerosol patients). As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, halo vision, conjunctival hyperemia, corneal edema, mydriasis, acute eye pain, dry throat, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported with the use of ipratropium bromide HFA inhalation aerosol. Additional adverse reactions identified for ipratropium bromide HFA inhalation aerosol seen in clinical trials include throat irritation, stomatitis, mouth edema, and vision blurred. Allergic-type reactions such as skin rash, pruritus, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported [see Warnings and Precautions ( 5.2 )]. 6.2 Post-Marketing Experience In a 5-year, placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving ipratropium bromide CFC inhalation aerosol. In addition to the adverse reactions reported in the controlled clinical trials, adverse reactions have been identified during post-approval use of ipratropium bromide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Allergic-type reactions such as skin rash, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported, with positive rechallenge in some cases. Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), cough and bronchospasm, including paradoxical bronchospasm, hypersensitivity reactions, intraocular pressure increased, accommodation disorder, heart rate increased, pharyngeal edema, and gastrointestinal motility disorders have been reported during the post-marketing period with use of ipratropium bromide.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Ipratropium Bromide Inhalation used for?
1 INDICATIONS AND USAGE Ipratropium bromide HFA inhalation aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Ipratropium bromide HFA inhalation aerosol is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic …

Who makes Ipratropium Bromide Inhalation?
Armstrong Pharmaceuticals, Inc. is the labeler of record for Ipratropium Bromide Inhalation.

What form does Ipratropium Bromide Inhalation come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Ipratropium Bromide Inhalation prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Ipratropium Bromide Inhalation been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.